NCT06399289

Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy

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레지스트리 요약

진행 상태: 완료 (COMPLETED)
질환/조건: Hemophilia B
시험 유형: 중재 연구 (INTERVENTIONAL)
단계: Phase 3
목적: 예방
중재 유형: 생물학적 제제
개입·치료: Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Lead Sponsor: CSL Behring (산업계)

캐시 시각: 2026-07-24 09:04:05

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요약

This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%). In addition to the scheduled rIX-FP prophylaxis regimen, subjects may also receive rIX-FP episodic (on-demand) treatment for breakthrough bleeding episodes and rIX-FP for the prophylaxis and treatment of bleeding in emergency surgical procedures.

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